"Our research suggests there are a plethora of high-quality, highly-innovative and potentially disruptive medical technology companies in the private sphere, many of whom could explore the IPO route over the next several quarters," Mills wrote in his report. "It’s never too early for investors to start learning about these compelling stories."

4C Medical Technologies is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitral regurgitation. According to the Brooklyn Park, MN-based company, it is the first transcatheter mitral regurgitation (MR) therapy that directly addresses MR without replacing the native mitral valve, thus preserving the native mitral annulus and left ventricle. 4C said its device is positioned supra annular to the leaking native mitral valve to stop the leak from entering the left atrium. Its atrial-only fixation ensures minimal disruption to critical cardiac structures within the left ventricle including the chordae tendineae and the left ventricular outflow tract, the company said. 4C Medical's initial focus is to develop a therapy for MR, and subsequently for tricuspid regurgitation.

"AltaValve holds the potential to treat up to 60% to 70% of TMVR patients, in management’s view, compared to the [approximate]10% to 40% rate able to be addressed by competitive TMVR platforms," Mills noted.

4C Medical Technologies Inc.

Cardiva Medical develops vascular access management products that facilitate rapid hemostasis following diagnostic and interventional endovascular procedures. The Santa Clara, CA-based company has introduced a series of advanced vascular access management technologies designed to help the body heal itself.

Cardiva filed for FDA approval in 2018 for its Vascade MVP vascular closure system designed specifically for multi-access venous closure following electrophysiology [EP] procedures such as arrhythmia ablation. John Russell, president and CEO of Cardiva, told MD+DI last November that Cardiva expects to be able to launch the new system during the first half of 2019. The company had a strong showing last year at the American Heart Association 2018 Scientific Sessions where results of the AMBULATE pivotal trial were presented.

"We think it’s the dawn of a new era for closure for EP procedures," Russell said at the time.

"Results from the [AMBULATE] study were compelling, with MVP delivering a statistically significant improvement in time to ambulation, total procedure time, time to discharge eligibility and time to hemostasis vs. manual compression," Mills noted in his report. "MVP also led to higher patient-reported satisfaction vs. manual compression on all metrics and a reduction in overall pain meds and opioid use.

The analyst said the EP market represents a highly concentrated market, with Cardiva estimate it would only need to be in about 200 accounts to reach about 50% of the current ablation market.

"On the competitive front, there is nothing directly on the radar targeting ablation closure, with Cardiva holding at least a three-year head start against competitive platforms, given the required PMA pathway."

Mills said Cheetah experienced some growing pains in the first half of 2018 as the firm tried to both expand the total number of accounts and achieve deeper penetration into existing accounts at the same time. However, he said Cheetah re-optimized its commercialization strategy in the second half of 2018 and the firm is entering 2019 primed to deliver stronger top-line growth: targeting revenue growth in excess of 25% in 2019. "Cheetah is planning to leverage its current sales infrastructure to drive growth in 2019, with management noting it could potentially look to add additional geographies to its current 20 territories over the next few years, with the potential addition of territory specialists further driving adoption down the road," Mills said.

Cheetah Medical Inc.

EndoGastric Solutions' (EGS) EsophyX fastener delivery system is designed to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids refluxing back into the esophagus. The Redmond, WA-based company's original EsophyX device and SerosaFuse fasteners were cleared by FDA in 2007. In 2017 the company debuted its latest version of the device, the EsophyX Z+.

The EsophyX device is used to perform the company’s TIF procedure (Transoral Incisionless Fundoplication), a surgical solution performed without the need for external incisions through the skin that enables physicians to reconstruct the gastroesophageal valve from within the stomach and correct the root cause of GERD.

"Over the past twelve months, EGS has significantly expanded its commercial team, including the addition of VPs of sales as well as marketing, in addition to building out its salesforce (with plans to continue to add feet on the street going forward)," Mills said in his report.

The analyst also noted that roughly 1,200 U.S. physicians are currently trained to do TIF procedures and EGS plans to leverage its expanding commercial team to drive further adoption, with a primary focus on targeting geographies with a high prevalence of GERD. Furthermore, the company touts an impressive amount of clinical data demonstrating the platform's safety, efficacy, and durability.

The Lisle, IL-based company raised $45 million in a series D financing round that closed in September 2018. The proceeds are intended to support the commercialization of the company's Cordella Heart Failure System and clinical development of the Cordella Pulmonary Artery Sensor through CE marking and FDA approval.

"Management views two, stand-alone $1 billion-plus market opportunities targeted by its patient management platform and its pulmonary sensor," Mills noted in his report. "The company expects its patient management platform to act as a leading product, helping feed patients into its sensor clinical trials."

Endotronix Inc.

Femasys develops medical devices intended to advance women's healthcare. The company's FemBloc device is a non-surgical permanent contraception system for women. The FemBloc consists of an implantable degradable biopolymer, designed to integrate with the local tissue and initiate a wound healing response. Injection of the biopolymer results in a durable tubal occlusion, with the polymer degrading post placement, and fully eliminated from the body within three months. FDA granted an investigative device exemption in January 2018, allowing the company to begin its BLOC pivotal clinical trial in the second quarter last year. Femasys currently markets the FemCerv, a device designed to optimize the diagnostic acuity of samples for cervical cancer screening, and the FemVue device, a system engineered to allow physicians to better assess patients’ fallopian tubes for infertility issues.

Mills said Femasys estimates a U.S. patient population of roughly 38 million seeking some form of contraception, 13 million of whom would be candidates for the firm’s permanent contraception platform. He also pointed out that Bayer’s exit from the market at the end of 2018 when it discontinued the Essure device "creates a significant void in treatment options that Femasys seeks to fill."

Pixabay/LJNovaScotia

Impulse Dynamics develops electrical therapies for the treatment of chronic heart failure. In December 2018 an FDA panel voted in favor of the company's Optimizer System for patients with moderate to severe systolic heart failure. CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart.

FDA previously granted Optimizer breakthrough device designation, given the lack of alternative device-based options for patients with moderate to severe heart failure and a normal QRS duration, Mills noted in his report. The analyst said FDA approval could come as early as the current quarter. ​​​​​

Pixabay

LimFlow's Percutaneous Deep Vein Arterialization (pDVA) System is designed to restore perfusion in the lower limbs of patients suffering from critical limb ischemia (CLI) by bypassing blocked arteries in the leg, allowing oxygenated blood to reach the foot, oftentimes resulting in immediate resolution of pain. Mills said the technology represents a fully percutaneous therapy capable of addressing patients where all alternative options have proven futile, a cohort of patients who today are faced with the prospect of major amputation. The pDVA System received CE mark in late 2016 and has been accepted into FDA’s breakthrough devices program. The Paris, France-based company continues to enroll its U.S. feasibility study (PROMISE I) as well as its International post-market study (PROMISE International), the analyst noted in his report.

Mills said CLI prevalence is forecast to continue to increase behind an increasing rate of diabetes coupled with a reduction in cardiovascular disease-driven mortality as therapies continue to improve. He said roughly 50% of CLI patients today progress to amputation without receiving any form of vascular intervention, with about 160,000 patients today reaching “no option” status. Those are the patients LimFlow is focused on targeting, he said.

Mercator Medsystems is focused on the treatment of peripheral artery disease (PAD) using its catheter-guided, micro-infusion systems for site-specific, non-systemic delivery of therapeutic agents directly across any blood vessel. The Emeryville, CA-based company's technology also enables therapies for vascular diseases, hypertension, oncology, and regenerative medicine. The company said its Bullfrog and Blowfish Micro-Infusion Devices are the first systems able to infuse drugs, genes, and cells safely through blood vessel or airway walls into deep tissues without major surgery.

"We view Mercator’s platform as complementary to atherectomy procedures, with Mercator adding additional value to stand-alone atherectomy," Mills said in his report. He noted that the platform has been used in more than 300 patients (both above the knee and below the knee) with results establishing a high safety profile for Bullfrog (no dissections or aneurysms).

"We think Mercator is increasingly well positioned behind its use of sirolimus in its TANGO trial," Mills said. "While the meta-analysis failed to highlight a mechanism of action or direct link between paclitaxel and mortality, we think the stigma around paclitaxel will ultimately act as a boon to Mercator, regardless of whether the results are substantiated on a broader scale."

Mercator MedSystems Inc.

Miracor Medical develops the PiCSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) Impulse System, a technology platform designed to improve clinical outcome of patients with impaired cardiac function. PiCSOAMI Therapy seeks to increase blood flow to the affected heart tissue, thereby improving the overall heart function after heart attack. Recent studies have demonstrated the positive effects of PiCSO on myocardial function and infarct size in acute heart attack patients, the Awans, Belgium-based company noted. The PiCSOAMI Impulse System consists of a driving console and associated catheters and offers the heart team new options to improve clinical outcome in heart attack patients.

"Management expects to commence its CE mark trial in the March/April timeframe, with results (conservatively) anticipated to be available in late 2020. In the U.S., the firm is planning a pre-sub with FDA in the next few months, with management optimistic around obtaining FDA IDE approval later this calendar year," Mills said in his report.

PulmonX sells the Zephyr Endobronchial Valve for the treatment of severe emphysema, with the valve specifically engineered to reduce hyperinflation of the diseased lung region. FDA approved the device last year through the breakthrough device designation.

During a bronchoscopic procedure requiring no cutting or incisions, Zephyr valves are placed in the airways to occlude a diseased part of the lungs and reduce hyperinflation. This helps the healthy parts of the lungs to expand and lifts pressure off the diaphragm, thereby decreasing shortness of breath and making breathing easier.

"PulmonX is focused on building a cornerstone in the emphysema space, with its Zephyr valve technology filling a huge void that exists across the treatment continuum today between rehab and surgery," Mills said.

PulmonX Inc.

Stimwave is developing a new, minimally invasive and wireless form of neuromodulation therapy for the treatment of chronic back and leg pain. The firm’s systems are powered by an external wearable power source, removing the need for future IPG replacement surgeries, with Stimwave’s wireless WaveCrest programming system enabling the delivery of multiple waveforms, allowing patients to customize and adjust the therapy as pain patterns evolve. Stimwave’s Freedom Stimulator device represents the smallest microstimulator currently on the market, able to be

placed via a standard gauge needle without surgery, Mills said. The Freedom SCS system is used to treat pain via the placement of electrodes in the epidural space of the spinal column, with additional electrodes able to be placed as needed. Stimwave also offers the StimQ PNS (peripheral nerve stimulator) system, with the system able to be placed to stimulate any peripheral nerve below the neck in order to mask the perception of pain. Both platforms hold FDA clearance and are MRI safe, the analyst noted.

Reflexion Medical's technology represents the first and only biology-guided radiotherapy system (BgRT) for personalized, targeted cancer treatment, and combines radiotherapy with PET imaging in a single machine. The Hayward, CA-based company is focused on addressing the limitations of current radiation therapy, with the RefleXion System engineered to enable the use of real-time biological signaling to target and irradiate multiple tumors accurately, in a single treatment session. Patients are injected with an imaging tracer with the system then leveraging PET imaging to identify tumors, with the technology directing therapeutic x-rays based on tumor-located tracer emissions. The system enables concomitant treatment of multiple tumors as well as real-time dose adaptation to target specific tumor characteristics.

V-Wave’s interarterial shunt is an hourglass-shaped implant placed in the interarterial septum via a minimally invasive transeptal procedure. The device is designed to help regulate left arterial pressure (LAP) by continuously diverting a portion of blood flow from the higher-pressure left atrium to the lower-pressure right atrium. Uncontrolled LAP elevation is the most common cause of acute heart failure hospitalizations. In October 2018 the company began its RELIEVE-HF global pivotal trial, designed to evaluate the safety and effectiveness of V- Wave’s shunt in severe HF patients with either preserved or reduced ejection fraction (HFpEF or HFrEF) who remain highly symptomatic despite optimal medical therapy.

Valencia Technologies developed the eCoin System, an electroceutical implant for the treatment of multiple chronic conditions, including overactive bladder (OAB). eCoin is a fully-implantable, leadless, coin-sized neurostimulater that is implanted during a routine 20-minute office procedure. In early feasibility studies, eCoin has demonstrated the ability to deliver comparable or better outcomes to current treatment options for OAB, without common side effects associated with traditional therapies, and in a less-invasive manner. In March 2018, the company announced FDA IDE approval to commence a pivotal trial for eCoin for the treatment of overactive bladder, with the trial commencing this past July. The Valencia, CA-based company is also planning to expand use of the eCoin System for other indications, including hypertension.

Vascular Dynamics' MobiusHD platform is a catheter-delivered, minimally invasive implant system for the treatment of drug-resistant high blood pressure, or hypertension. The device is comprised of a nitinol implant delivered via catheter to the carotid sinus and is designed to enhance signals generated by the surrounding arterial baroreceptors, leading to peripheral blood vessel dilation and a subsequent reduction in systemic blood pressure. The system is specifically designed to reduce hypertension without inhibiting the body’s natural ability to modulate blood pressure. MobiusHD received CE mark approval in January 2016 and is currently being evaluated in the CALM-2 U.S. pivotal trial to support FDA clearance, Mills reported.

"The company sees additional opportunities over the long-term to expand into Japan, where competitors are currently enrolling smaller studies in the region," Mills said.